Events

Field Safety Notices about Pangea Spine System, and others

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-09-08
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Technique guides for the systems mentioned above describe the pedicle awls as 4.0mm for use with screws (4.0mm — 7.0mm). these awls should be used with 5.0mm — 7.0mm screws. this field safety notice is being issued in order to communicate changes being made to technique guides and outer labels in order to clarify the intended use of these two awls within these systems. there has been no change to the design or manufacture of the pedicle awls.

Device

Pangea Spine System, and others
  • Model / Serial
    Pangea Spine System, Technique Guide 036000.080 USS ll Polyaxial Spine System, Technique Guide 036000.216 MATRIX Spine System — Deformity, Technique Guide 036.001.180 MATRIX Spine System — Degenerative, Technique Guide 036.001.185 *Pangea Degenerative, Technique Guide 036.000.445 ’The Pangea Degenerative, Technique Guide (Technique Guide Number 036.000.445) has been added to this Field Safety Notice. Affected Labeling Description . Product Code Pedicle Awl 4.0mm wlCanevasit Handle 388.550 Pedicle Awl 4.0mm wlSiIicone Handle 388.656
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH